The Essential List of Regulatory Authorities in Europe Posted 22 January 2020 | By Michael Mezher The Essential List of Regulatory Authorities in Europe To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list is organized by regional affiliation with the European Union (EU), European Free Trade Association (EFTA) and other European countries. For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unclear. Additionally, some of the agencies listed do not appear to have websites, or the websites are not functioning as of this publication. If you notice an issue with this page or wish to submit a correction please email Focus at news@raps.org. Country Drug Regulatory Authority Medical Devices Regulatory Authority Ministry of Health European Union (EU) Austria Federal Office for Safety in Health Care (BASG) Federal Office for Safety in Health Care (BASG) Federal Ministry of Labour, Social Affairs, Health and Consumer Protection Belgium Federal Agency for Medicines and Health Products (FAMHP) Federal Agency for Medicines and Health Products (FAMHP) Federal Public Service (FPS) Health, Food Chain Safety and Environment Bulgaria Bulgarian Drug Agency (BDA) Bulgarian Drug Agency (BDA) Ministry of Health Croatia Agency for medicinal products and medical devices of Croatia (HALMED) Agency for medicinal products and medical devices of Croatia (HALMED) Ministry of Health Cyprus Ministry of Health – Pharmaceutical Services Ministry of Health – Medical & Public Health Services, Cyprus Medical Devices Competent Authority Ministry of Health Czech Republic State Institute for Drug Control (SUKL) State Institute for Drug Control (SUKL) Ministry of Health of the Czech Republic Denmark Danish Medicines Agency Danish Medicines Agency Ministry of Health Estonia Agency of Medicines Health Board, Medical Devices Ministry of Social Affairs Finland Finnish Medicines Agency (FIMEA) Finnish Medicines Agency (FIMEA) Ministry of Social Affairs and Health France National Agency for Medicines and Health Products Safety (ANSM) National Agency for Medicines and Health Products Safety (ANSM) Ministry for Solidarity and Health Germany Federal Institute for Drugs and Medical Devices (BfArM), Paul-Ehrlich-Institut (PEI) Federal Institute for Drugs and Medical Devices (BfArM) Federal Ministry of Health Greece National Organization for Medicines National Organization for Medicines Ministry of Health Hungary National Institute of Pharmacy and Nutrition Department for Medical Devices, National Institute of Pharmacy Ministry of Human Capacities Ireland Health Products Regulatory Authority (HPRA) Health Products Regulatory Authority (HPRA) Department of Health Italy Italian Medicines Agency (AIFA) Directorate-General for Medical Devices and Pharmaceutical Service Ministry of Health Latvia State Agency of Medicines State Agency of Medicines Ministry of Health of the Republic of Latvia Lithuania State Medicines Control Agency State Health Care Accreditation Agency Ministry of Health of the Republic of Lithuana Luxembourg Ministry of Health Ministry of Health Ministry of Health Malta Medicines Authority Malta Competition and Consumer Affairs Authority Ministry for Health Netherlands Medicines Evaluation Board, Farmatec Farmatec Ministry of Health, Welfare and Sport Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Ministry of Health Portugal Infarmed Infarmed Ministry of Health Romania The National Agency for Medicines and Medical Devices (NAMMD) The National Agency for Medicines and Medical Devices (NAMMD) Ministry of Health Slovakia State Institute for Drug Control (SUKL) State Institute for Drug Control (SUKL) Ministry of Health of the Slovak Republic Slovenia Agency for Medicines and Medical Devices (JAZMP) Agency for Medicines and Medical Devices (JAZMP) Ministry of Health Spain Spanish Agency of Medicines and Medical Products (AEMPS) Spanish Agency of Medicines and Medical Products (AEMPS) Ministry of Health, Consumer Affairs and Social Welfare Sweden Medical Products Agency Medical Products Agency Ministry of Health and Social Affairs United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) Medicines and Healthcare products Regulatory Agency (MHRA) Department of Health and Social Care European Free Trade Association (EFTA) Iceland Icelandic Medicines Agency Icelandic Medicines Agency Ministry of Health Liechtenstein Office of Health Office of Health Office of Health Norway Norwegian Medicines Agency Norwegian Medicines Agency Ministry of Health and Care Services Switzerland Swissmedic Swissmedic Federal Office of Public Health (FOPH) Other Countries Albania Ministry of Health Andorra Ministry of Health Belarus Center for Expertise and Testing in Healthcare Center for Expertise and Testing in Healthcare Ministry of Health Bosnia and Herzegovina The Agency for Medicinal Product and Medical Devices The Agency for Medicinal Product and Medical Devices Federal Ministry of Health Macedonia Agency for Medicinal Products and Medical Devices Agency for Medicinal Products and Medical Devices Ministry of Health Moldova Medicines and Medical Devices Agency Medicines and Medical Devices Agency Ministry of Health, Labour and Social Protection Montenegro Agency for Medicines and Medical Devices of Montenegro Agency for Medicines and Medical Devices of Montenegro Ministry of Health San Marino Ministry of Health and Social Security Serbia Medicines and Medical Devices Agency of Serbia Medicines and Medical Devices Agency of Serbia Ministry of Health Ukraine State Service of Ukraine on Medicines and Drug Control State Service of Ukraine on Medicines and Drug Control Ministry of Health